Effects of Mindfulness Based Cognitive Therapy on Emotional Processing

NCT03358056 | Unknown

• 1 other identifier: 2017/7185/I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In the last 30 years mindfulness-based approaches have been extensively used for a variety of mental disorders, including affective disorders characterized by emotional instability. Mindfulness based cognitive therapy (MBCT) is an 8-week intervention that combines mindfulness practices with cognitive behavioural therapy. Although changes in emotional processing have been postulated as one of mindfulness mechanisms of action, the effects of mindfulness-based programs on objective tasks of emotional processing have been poorly studied. Objective: To explore the effects of mindfulness-based cognitive therapy (MBCT) on emotional processing in a sample of individuals with emotional instability attended in a mental-health public service. Methods: The sample (n = 30) will be recruited from public mental-health outpatient centers in Barcelona, Spain. Inclusion criteria: 1) high emotional instability defined as scores above 96 on the Difficulties in Emotion Regulation Scale (DERS), 2) age between 18 and 65 years, 4) no prior experience with mindfulness/meditation. Exclusion criteria: 1) risk of suicide (attempted suicide in the last year or current suicidal ideation). Psychotropic medication will be permitted, as long as there are no changes in dose/type during the study period. Measures Diagnostic measures (MINI, DERS, CGI) and a complete medical register will be collected prior inclusion in the study. Additional measures on personality (ZKPQ) and temperament (Temps-A) will be collected as well. Primary outcome: Emotional processing task: Participants will complete the FERT task at two time points: baseline (pre-treatment) and 8 weeks (post-treatment). Secondary outcomes: In addition, participants will complete the following assessments (pre-and-post- treatment):

• Depressive Symptoms (QIDS-16)
• Anxiety Symptoms (STAI)
• Mindfulness (FFMQ and EQ). Treatment Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily sensations, thoughts and feelings associated with negative emotional states. Mindfulness exercises and cognitive-behavioral skills are practiced both during the sessions and through homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive weeks.

Conditions

Unipolar Depression; Anxiety Disorders; Adjustment Disorders; Emotional Instability

Keywords

Mindfulness; Emotion; Mindfulenss-based cognitive therapy

Outcome Measures

Primary Outcomes (1)

• Facial Emotion Recognition Task

  Computarized facial emotion recognition task

  8 past weeks

Secondary Outcomes (1)

• Quick Depression Inventory

  1 past week

Study Arms (1)

Mindfulness-based Cognitive Therapy

EXPERIMENTAL

Behavioral: Mindfulness-Based Cognitive Therapy

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily sensations, thoughts and feelings associated with negative emotional states. Mindfulness exercises and cognitive-behavioral skills are practiced both during the sessions and through homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive weeks.

Mindfulness-based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• high emotional instability defined as scores above 96 on the Difficulties in Emotion Regulation Scale (DERS)
• diagnosis of unipolar affective disorders
• age between 18 and 65 years
• no prior experience with mindfulness/meditation

You may not qualify if:

• risk of suicide (attempted suicide in the last year or current suicidal ideation.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Parc de Salut Mar

Barcelona, 08003, Spain

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Adjustment Disorders

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Matilde Elices, Dr

CONTACT

+34 646096104; melices@imim.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 30, 2017
• Study Start: September 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 30, 2017

Record last verified: 2017-10

Locations

ES (1)